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Last Updated: November 28, 2020

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Claims for Patent: 8,778,394

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Summary for Patent: 8,778,394
Title:Small-volume oral transmucosal dosage forms
Abstract: Small-volume oral transmucosal dosage forms or NanoTabs.RTM. comprising a predetermined amount of a pharmaceutically active drug are provided. Exemplary applications include use of the NanoTabs.RTM. to administer a drug for the treatment of acute, post-operative or breakthrough pain.
Inventor(s): Palmer; Pamela (San Francisco, CA), Schreck; Thomas (Portola Valley, CA), Tzannis; Stelios (Petaluma, CA), Hamel; Larry (Pacific Grove, CA), Poutiatine; Andrew I. (Mill Valley, CA)
Assignee: AcelRx Pharmaceuticals, Inc. (Redwood City, CA)
Application Number:13/561,543
Patent Claims: 1. A method of treating pain in a subject, comprising administering a single dose of sufentanil to the oral mucosa of a subject, wherein the single dose is provided as a small volume solid tablet, and said solid tablet comprises: from about 0.25 micrograms (mcg) to 200 micrograms sufentanil, wherein; a) said solid tablet is bioadhesive and adheres to the oral mucosa of said subject, b) said solid tablet is a substantially homogeneous composition and has a volume of less than 30 microliters (mei); and c) after administration of said solid tablet to said subject, said solid tablet provides a minimal saliva response and minimal swallowing of sufentanil; at least 55% of drug delivery of sufentanil occurs via the oral transmucosal route; said solid tablet provides a dose-normalized C.sub.max of about 2.72+/-0.84 pg/mL per mcg dosed.

2. The method according to claim 1, wherein complete erosion of said solid tablet is evident by visual examination in about 30 seconds up to about 15 minutes following administration.

3. The method according to claim 1, wherein the erosion time of said solid tablet is about 10 minutes.

4. The method according to claim 1, wherein said solid tablet has a volume of less than 10 mcl.

5. The method according to claim 1, wherein said oral transmucosal administration is sublingual administration.

6. The method according to claim 1, wherein said oral transmucosal administration is buccal administration.

7. The method according to claim 1, comprising from about 2.5 micrograms to 100 micrograms of sufentanil.

8. The method according to claim 7, wherein said solid tablet comprises a dose of sufentanil selected from the group consisting of 5 micrograms, 10 mcg, 15 mcg, 20 mcg, 30 mcg, 40 mcg, 50 mcg, 60 mcg, 70 mcg, 80 mcg and 100 mcg.

9. The method according to claim 1, wherein a single oral transmucosal administration of said solid tablet to a subject results in a sufentanil bioavailability of greater than 65%.

10. The method according to claim 1, wherein a single oral transmucosal administration of said solid tablet to a subject results in a sufentanil bioavailability of greater than 75%.

11. The method according to claim 1, wherein a single oral transmucosal administration of said solid tablet to a subject results in a sufentanil bioavailability of greater than 85%.

12. The method according to claim 1, wherein at least 60% of the total amount of sufentanil in said solid tablet is absorbed via the oral transmucosal route.

13. The method according to claim 1, wherein said solid tablet is administered using a drug delivery device.

14. The method according to claim 1, wherein when solid tablet is subjected to an in vitro dissolution test in a Type II USP dissolution apparatus, at least 75% of the total amount of sufentanil in said solid tablet is released within 10 minutes.

15. The method according to claim 1, wherein sufentanil is provided as sufentanil citrate.

16. The method according to claim 1, wherein after administration of said tablet to said subject, said solid tablet provides a T.sub.max range of from about 19.8 minutes to about 60 minutes.

17. The method according to claim 1, wherein after administration of said tablet to said subject, said solid tablet provides a T.sub.max with a coefficient of variation of less than 40%.

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